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Stress Hormones and IUDs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499379
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Nora Doty, MD, Oregon Health and Science University

Brief Summary:
Determine what kind of side effects women experience in the first year after they start using an intrauterine device.

Condition or disease Intervention/treatment
Contraception Mood Change Device: Mirena Device: Paraguard

Detailed Description:
The purpose of this study is to find out if there is a difference in levels of stress hormones in women who use copper or hormonal intrauterine devices (IUDs). This study will provide more information on the potential effect of levonorgestrel intrauterine system (LNG-IUS) use on an individual's stress response. Ultimately, this study hopes to provide data to better counsel women on potential mood effects of the LNG-IUS. From a research and clinical management perspective, hair cortisol may provide a tool to evaluate women at risk for discontinuation of hormonal contraception due to concern of mood symptoms.

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
Women initiating use of an intrauterine device

Women obtaining a copper or hormonal intrauterine device for the purpose of contraception.

A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex will be taken at the time of IUD insertion, 6 months post-insertion, and 12 months post-insertion.

Device: Mirena
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Other Name: levonorgestrel intrauterine system

Device: Paraguard
A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
Other Name: Copper T380A IUD




Primary Outcome Measures :
  1. Mean change in hair cortisol concentration - 6 months [ Time Frame: Baseline & 6 months post-insertion ]
    A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 6 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 6 months.


Secondary Outcome Measures :
  1. Mean change in hair cortisol concentration - 12 months [ Time Frame: Baseline & 12 months post-insertion ]
    A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 12 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 12 months.


Biospecimen Retention:   Samples With DNA

A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex.

Whole blood samples collected at each study visit (approximately 10mL). The serum from those samples will tested for hormone levels.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be selected from women's health care clinics in the community.
Criteria

Inclusion Criteria:

  • Generally healthy
  • Age 18-39 years
  • Regular menstrual cycles
  • Getting an IUD for the purpose of contraception

Exclusion Criteria:

  • History of mood disorders
  • BMI less than 18.5 or greater than 35
  • Chronic medical conditions
  • Recently pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499379


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
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Principal Investigator: Nora Doty, MD Oregon Health and Science University
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Responsible Party: Nora Doty, MD, Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03499379    
Other Study ID Numbers: OHSU IRB 18244
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nora Doty, MD, Oregon Health and Science University:
Intrauterine device (IUD)
Depression
Stress hormones
Mood changes
Additional relevant MeSH terms:
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Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral